[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639341":3},{"organization":4,"outcomesModule":7,"designInfo":83,"detailedDescription":92,"studyPopulation":86,"armGroups":93,"interventions":106,"overallOfficials":86,"centralContacts":115,"locations":121,"responsibleParty":137,"collaborators":139,"id":145,"slug":86,"hasResults":146,"nctId":147,"briefTitle":148,"officialTitle":148,"acronym":86,"eligibilityCriteria":149,"healthyVolunteers":146,"sex":150,"minAge":151,"maxAge":86,"enrollmentInfo":152,"targetDuration":86,"studyType":155,"phases":156,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":123,"whyStopped":86,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"Florida Atlantic University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":45},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Adherence","Adherence will be calculated based on the percentage of prescribed sessions attended and percentage of participants who complete the prescribed exercise and tACS sessions.","From baseline to the end of the 4-week intervention",{"measure":14,"description":15,"timeFrame":12},"Retention","Retention will be determined by the number of enrolled breast cancer survivors who participate in the four-week intervention and complete post assessments.",{"measure":17,"description":18,"timeFrame":12},"Acceptability","Acceptability will be determined by the percentage of participants who report satisfaction with the intervention.",{"measure":20,"description":21,"timeFrame":12},"Safety (Adverse Events)","Safety (\\\u003C5% of serious adverse events) will be determined by the percentage of participants experiencing a serious adverse event related to the program.",[23,27,30,33,36,39,42],{"measure":24,"description":25,"timeFrame":26},"Sustained attention","Researchers will assess pre- to post-intervention changes in sustained attention, measured by performance on the AX-Continuous Performance Test (AX-CPT).","Baseline, within 2 weeks following the intervention, and 4-week follow-up",{"measure":28,"description":29,"timeFrame":26},"Executive function","Researchers will assess pre- to post-intervention changes in executive function, measured by performance (time) on the Trail Making Test Part A (TMT-A) and Part B (TMT-B).",{"measure":31,"description":32,"timeFrame":26},"Inhibitory control","Researchers will assess pre- to post-intervention changes in inhibitory control, measured by performance on the Flanker Compatibility Task.",{"measure":34,"description":35,"timeFrame":26},"Working Memory","Researchers will assess pre- to post-intervention changes in working memory, measured by performance on the N-back and Backwards Counting tasks.",{"measure":37,"description":38,"timeFrame":26},"Subjective Cognition","Researchers will assess pre- to post-intervention changes in subjective cognition, measured by the Functional Assessment Cancer Therapy-Cognition (FACT-COG)",{"measure":40,"description":41,"timeFrame":26},"Physical Function","Researchers will assess pre- to post-intervention changes in lower body physical function, measured by the 30-second chair stand.",{"measure":43,"description":44,"timeFrame":26},"Cardiorespiratory endurance","Researchers will assess pre- to post-intervention changes in cardiorespiratory fitness, measured by the six-minute walk test.",[46,49,52,55,58,61,64,67,70,73,76,79],{"measure":47,"description":48,"timeFrame":26},"Body fat percentage","Researchers will assess pre- to post-intervention changes in body fat percentage measured via bioelectrical impedance analysis using the BIA-ACC (BioTekna) device.",{"measure":50,"description":51,"timeFrame":26},"Learning and Memory","Researchers will assess pre- to post-intervention changes in learning and memory, assessed by the California Verbal Learning Test.",{"measure":53,"description":54,"timeFrame":26},"Quality of Life (FACT-B)","Researchers will assess pre- to post-intervention changes in quality of life, measured by the Functional Assessment of Cancer Therapy - Breast. Scores range from 0-148, with higher scores indicating better quality of life.",{"measure":56,"description":57,"timeFrame":26},"Fatigue (FACIT-F)","Researchers will assess pre- to post-intervention changes in fatigue, measured by the Functional Assessment of Chronic Illness Therapy-Fatigue. Scores range from 0-52, with higher scores indicating less fatigue.",{"measure":59,"description":60,"timeFrame":26},"Perceived exercise benefits and barriers","Researchers will assess pre- to post-intervention changes in perceived benefits and barriers to exercise, measured by the Exercise Benefits\u002FBarriers Scale (EBBS). Benefit scores range from 29-116, with higher scores indicating greater perceived benefits. Barrier scores range from 14-56, with higher scores indicating greater perceived barriers.",{"measure":62,"description":63,"timeFrame":26},"Physical Function (Short Physical Performance Battery)","Researchers will assess pre- to post-intervention changes in physical function, assessed using the Short Physical Performance Battery. Scores range from 0-12, with higher scores indicating better physical function.",{"measure":65,"description":66,"timeFrame":26},"Muscle Power","Researchers will assess pre- to post-intervention changes in lower body muscle power, measured by a single sit-to-stand using the Tendo Power Analyzer.",{"measure":68,"description":69,"timeFrame":26},"Grip strength","Researchers will assess pre- to post-intervention changes in grip strength, measured using a hand-held grip strength dynamometer",{"measure":71,"description":72,"timeFrame":26},"Upper body physical function","Researchers will assess pre- to post-intervention changes in upper body physical function, measured by the 30-second arm curl test.",{"measure":74,"description":75,"timeFrame":26},"Fall Risk","Researchers will assess pre- to post-intervention changes in fall risk, measured by the Falls Efficacy Scale. Scores range from 16-64, with higher scores indicating greater fall risk.",{"measure":77,"description":78,"timeFrame":26},"Physical Activity","Researchers will assess pre- to post-intervention changes in physical activity, measured by an accelerometer.",{"measure":80,"description":81,"timeFrame":82},"Skeletal Muscle","Description: Researchers will assess pre- to post-intervention changes in skeletal muscle (kg) measured via bioelectrical impedance analysis using the BIA-ACC (BioTekna) device","Baseline, within two weeks following the intervention, 4-week follow-up",{"allocation":84,"interventionModel":85,"interventionModelDescription":86,"primaryPurpose":87,"observationalModel":86,"timePerspective":86,"maskingInfo":88},"RANDOMIZED","PARALLEL",null,"SUPPORTIVE_CARE",{"masking":89,"maskingDescription":86,"whoMasked":90},"SINGLE",[91],"PARTICIPANT","Breast cancer is one of the most common forms of cancer among women in the United States. Although advances in cancer treatments have led to improved survival rates, breast cancer survivors must contend with the negative side effects from the cancer and its treatments. One of the most common and highly distressing treatment side effects is cancer-related cognitive impairment (CRCI), which is characterized by losses in memory, attention, processing speed, and executive function, which make daily tasks such as recalling information, organizing daily routines, concentrating, and multitasking more challenging. Findings from previous studies support aerobic exercise training as an effective strategy for improving cognitive function. In addition, non-invasive brain stimulation (NIBS), a technique in which electrodes are applied to the skin to noninvasively stimulate specific regions of the brain, has also been found to be a safe and effective approach for improving cognitive outcomes. Among various NIBS techniques, transcranial alternating current stimulation (tACS), which delivers current to the brain in an alternating pattern, may be a promising strategy for improving cognitive outcomes. Few studies have explored these approaches in breast cancer survivors, and to our knowledge, the combination of exercise and tACS (Ex+tACS) has not been explored.\n\nThis study will assess the feasibility of a 4-week Ex+tACS intervention in breast cancer survivors who report cancer-related cognitive impairment. Researchers will also examine changes in attention, executive function, working memory, perceived cognitive function, and physical function before, after, and four weeks post intervention completion in the Ex+tACS group compared to a control group who will receive exercise and a placebo tACS condition (CON).",[94,100],{"label":95,"type":96,"description":97,"interventionNames":98},"Intervention Arm","EXPERIMENTAL","The Exercise + transcranial alternating current stimulation (Ex+tACS) group will complete a four-week intervention consisting of 3 days\u002Fweek of 30 minutes of aerobic exercise on a treadmill at a sustained moderate intensity, immediately followed by 15 min of tACS. During tACS, 6Hz alternating current stimulation will be administered to participants' prefrontal cortex (forehead region) using a tACS while the participant completes the AX Continuous Performance Test (AX-CPT).",[99],"Behavioral: Exercise + transcranial alternating current stimulation (Ex+tACS)",{"label":101,"type":102,"description":103,"interventionNames":104},"Control","SHAM_COMPARATOR","The Sham Comparator group will complete 30 minutes of aerobic exercise on the treadmill followed by the Sustained Attention-Continuous Performance Task (AX-CPT) with a sham transcranial alternating current stimulation (tACS) condition. The same procedures will be followed regarding the tACS, but stimulation will only last one minute, ramping up and down at the beginning and end of the 15-minute period, simulating the periodic tingling sensation that are reported with tACS.",[105],"Behavioral: Control",[107,112],{"type":108,"name":109,"description":110,"armGroupLabels":111,"otherNames":86},"BEHAVIORAL","Exercise + transcranial alternating current stimulation (Ex+tACS)","The Ex+tACS group will complete a four-week intervention consisting of 3 days\u002Fweek of 30 minutes of aerobic exercise on a treadmill at a sustained moderate intensity, immediately followed by 15 min of tACS while completing the AX Continuous Performance Test (AX-CPT).",[95],{"type":108,"name":101,"description":113,"armGroupLabels":114,"otherNames":86},"The Control (CON) group will complete 30 minutes of aerobic exercise on the treadmill followed by the Sustained Attention-Continuous Performance Task (AX-CPT) with a sham tACS condition. After each session, both the EX+tACS and control participants will complete a questionnaire regarding experience with tACS.",[101],[116],{"name":117,"role":118,"phone":119,"phoneExt":86,"email":120},"Ashley L Artese, PhD","CONTACT","856-534-8926","aartese@fau.edu",[122],{"facility":5,"status":123,"city":124,"state":125,"zip":126,"country":127,"countryCode":128,"cosmosGeoPoint":129,"geoPoint":134,"contacts":135},"RECRUITING","Boca Raton","Florida","33431","United States","US",{"type":130,"coordinates":131},"Point",[132,133],-80.0831,26.35869,{"lat":133,"lon":132},[136],{"name":117,"role":118,"phone":119,"phoneExt":86,"email":120},{"type":138,"investigatorFullName":86,"investigatorTitle":86,"investigatorAffiliation":86,"oldNameTitle":86,"oldOrganization":86},"SPONSOR",[140,142],{"name":141,"class":6},"Memorial Sloan Kettering Cancer Center",{"name":143,"class":144},"Florida Department of Health","OTHER_GOV","100639341",false,"NCT07587957","Exploring the Feasibility of an Exercise and Noninvasive Brain Stimulation Intervention in Breast Cancer Survivors","Inclusion Criteria:\n\n* Breast cancer survivors (≥18 years) will be eligible to participate if the following inclusion criteria is met:\n* Diagnosed non-metastatic breast cancer (stages 0-3)\n* Completed primary breast cancer treatment (surgery, chemotherapy, radiation) for at least 3 months\n* Self-reported cognitive impairment after cancer treatment\n\nExclusion Criteria:\n\n* Current participation in aerobic exercise for ≥60 min\u002Fwk\n* Contraindication or impairment that precludes the potential participant from exercise as defined by the American College of Sports Medicine\n* The presence of serious medical illnesses, metal implants, previous brain trauma, epilepsy or history of seizures, previous surgery to the head or spinal cord, or skin problems at the forehead area where the tACS electrodes will be applied\n* Uncontrolled cardiovascular disease\n* Functional impairments or physical condition that would make exercise unsafe\n* Metastatic cancer or diagnosis of a different cancer (excluding melanoma) within the past 5 years\n* Contraindication to exercise a defined by the American College of Sports Medicine","ALL","18 Years",{"count":153,"type":154},40,"ESTIMATED","INTERVENTIONAL",[157],"NA","The purpose of this study is to assess the feasibility of a 4-week intervention combining exercise and transcranial alternating current stimulation (Ex+tACS) in breast cancer survivors who report experiencing cancer-related cognitive impairment. Feasibility will be assessed by measuring participant retention, adherence, satisfaction with the intervention, and safety. The researchers will also examine pre-to-post intervention changes in attention, executive function, working memory, perceived cognitive function, and physical function before, after, and four weeks post intervention completion in the Ex+tACS group compared to a control group who will receive exercise and a placebo tACS condition (CON).",[160],"Breast Cancer",[160,162,163,164],"Cancer-related cognitive impairment","Non-invasive brain stimulation","Exercise","2026-05-07",{"date":167,"type":168},"2026-05-14","ACTUAL",{"date":170,"type":168},"2026-01-07",{"date":172,"type":154},"2027-01-01",{"name":5,"class":6},1]